FDA Developing E-Cigarette Standards and Nicotine Policy

The U.S. Food and Drug Administration (FDA) is developing standards for electronic cigarettes and other nicotine delivery devices, in order to protect public health and enable the agency to withstand legal challenges.

Mitchell Zeller, an attorney, and director of the FDA’s Center for Tobacco Products, said the agency is exploring product standards in the areas of addiction, toxicity, and product appeal as it prepares to gain regulatory authority over electronic cigarettes and other nicotine-delivery devices, Reuters reports. The FDA will put into place regulations for approving new products and monitoring them after they reach the market. The FDA wants to have a strong compliance and law enforcement presence in every state, along with public education programs, and a nicotine policy that recognizes that some products are more risky than others.

The benefits and risks of e-cigarettes are the subject of intense debate. “It’s not the nicotine that kills half of all long-term smokers, it’s the delivery mechanism,” Zeller said this week at an event organized by the American Legacy Foundation, an anti-tobacco group.

Under the 2009 Tobacco Control Act, FDA has the authority to ban or restrict ingredients and compounds in a particular product, if there is scientific evidence to support the policy. In April the FDA proposed rules that would ban the sale of e-cigarettes to people under the age of 18 and subject the $2 billion industry to federal regulation for the first time. The proposal, however, would not restrict flavored products, or online sales or advertising, which public health advocates hoped the rules would do. They argue that fruit and candy flavors of liquid nicotine attract children to e-cigarettes, or the liquid itself. As little as a teaspoon of liquid nicotine can be fatal to a small child, The New York Times reports. Poison control centers have reported a significant increase in calls related to nicotine toxicity.

Experts disagree over the role of e-cigarettes, according to the Times. Some argue that the devices offer a safer alternative to the deadly compounds in cigarette smoke and by cutting down on tobacco-containing cigarettes, they could save millions of lives. But others argue that e-cigarettes pose their own dangers and, further, that they can be a way to introduce smoking, not as a way to assist smokers to quit.

Zeller said further research is needed to assess the impact of e-cigarettes on the overall health of the population, according to Reuters. He said it is important to keep in mind the bigger picture: “tobacco use remains the leading cause of preventable death and disease principally because of the ongoing use of products that burn tobacco.”